SPCinverted black triangle symbol ▼ next to the product name has been deleted.

Updated on 01-Nov-2011 and displayed until 09-Mar-2012

Reasons for adding or updating:

Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 01-Oct-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

﻿SmPC Section 4.4 updated to include an angioedema warning.

Updated on 04-Apr-2011 and displayed until 01-Nov-2011

Reasons for adding or updating:

Change to section 4.2 - Posology and method of administration

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.8 - Undesirable Effects

Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Mar-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

﻿

Section 4.2: Deletion of sentence: During concomitant administration of a moderate CYP3A4 inhibitor, a dose increase to 8 mg should be preceded by an evaluation of the individual response and tolerability (see sections 4.4 and 4.5).”

Change to posology table footnote for moderate CYP3A4 inhibitors.

Section 4.5:

Metoclopromide spelling amended to metoclopramide

saquinivir spelling amended to saquinovir

Replacement text included on use with moderate and weak CYP3A4 inhibitors.

Updated on 03-Nov-2010 and displayed until 16-Feb-2011

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 25-Oct-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

﻿A clinical study in healthy volunteers has shown that fesoterodine 8 mg
once daily has no significant effect on the pharmacokinetics or the
anticoagulant activity of a single dose of warfarin.

Updated on 12-Jul-2010 and displayed until 03-Nov-2010

Reasons for adding or updating:

Change to section 4.4 - Special warnings and precautions for Use

Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Jun-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

﻿

Update to section 4.4 to provide example of patients at risk of urinary retention (BPH) and section 4.8 to add further information about urinary retention and add the uncommon side effect of gastroesophageal reflux.